ARTICLE SUMMARY:
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in April 2023. Updated April 30, 2023.
A roundup of FDA’s actions in April 2023
| NOVEL DEVICE APPROVALS |
||||||
| Company |
Device |
Date |
Approval Type |
Approval Number |
||
| BlackSwan Vascular |
lava liquid embolic system |
4/4/23
|
Original PMA | P220020 | ||
| Candesant Biomedica | The N-SWEAT Patch | 4/7/23 | De Novo | DEN 210055 |
||
| Moximed | MISHA Knee System | 4/10/23 | De Novo | DEN2 20033 | ||
| Noctrix Health | NTX100 Tonic Motor Activation |
4/17/23 | De Novo | DEN220059 | ||
| Empower Medical Devices | Bateman Bottle | 4/20/23 | De Novo | DEN220082 | ||
| Medtronic Minimed | minimed 780g system | 4/21/23 | Panel-track supplement | P 160017 S091 |
||
| Alcon Laboratories | precision7 for astigmatism |
4/25/23 | Original PMA | P220007 | ||
| Q-Med | sculptra | 4/25/23 | Panel-track supplement | P 030050 S039 | ||
| Tempus Labs | xt cdx | 4/27/23 | Original PMA | P220011 | ||
| Siemens Healthcare Diagnostics | advia centaur anti-hbc total (hbct2) and atellica ... | 4/28/23 | Panel-track supplement | P 210019 S002 | ||
| BREAKTHROUGH DEVICES |
||||||
| Sponsor |
Device | Clinical Target |
Date |
|||
| Reach Neuro | Avantis neuromodulation platform | Post-stroke movement restoration | 4/10/23 | |||
| Genetesis | CardioFlux MCG | Myocardial ischemia | 4/13/23 | |||
| BioPoly | BioPoly synthetic cartilage | Knee cartilage damage | 4/14/23 | |||
| Ultromics | EchoGo Amyloidosis | Cardiac amyloidosis | 4/26/23 | |||
| Promis Diagnostics |
EarlyTect-BCD
|
Bladder cancer detection | 4/26/23 | |||
| Innoblative Designs | SIRA RFA Electrosurgical Device | Breast cancer | 4/27/23 | |||
| WARNING LETTERS |
||||||
| Company |
Citations |
Posting Date |
Issuing Office |
|||
| Premarket |
4/4/23 | OHT 6: Office of Orthopedic Devices | ||||
| Abbott Point of Care Canada | Premarket | 4/18/23 | OHT 7: Office of In Vitro Diagnostics | |||
| North American Diagnostics | Premarket | 4/18/23 | OHT7: Office of In Vitro Diagnostics | |||
| Medivance Instruments | Premarket | 4/25/23 | OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices |
|||
| CLASS 1 RECALLS |
||||||
| Company |
Device |
Date |
Recall Number |
|||
| Baxter Healthcare | Automated Peritoneal Dialysis System |
4/1/23 |
|
|||
| Philips Respironics | TrilogyEvo and LifeVent portable electric ventilators, var. |
4/3/233 | Z-1286-2023 & Z-1289-2023 |
|||
| Philips Respironics | Philips DreamStation Auto BiPAP and CPAP |
4/6/23 | Z-1316-2023 | |||
| Abbott Diabetes Care | FreeStyle Libre readers, var. | 4/7/23 | Z-1273-2023 through Z-1275-2023 | |||
| Fresenius Kabi USA | Ivenix Infusion System, Large Volume Pump |
4/18/23 | Z-1313-2023 | |||
| Covidien | Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff |
4/19/23 | Z-1357 -2023 | |||
| NEW DIAGNOSTIC EMERGENCY USE AUTHORIZATIONS |
||||||
| Test Kit Manufacturer & Commercial Labs |
Date |
|||||
| Azure Biotech, Azure FaStep COVID-19 Antigen Pen Home Test |
4/14/23 | |||||
| MedArbor Diagnostics, MedArbor Diagnostics SARS-CoV-2 Assay | 4/19/23 | |||||
| Princeton BioMeditech, Status COVID-19 Antigen Rapid Test for Home Use | 4/24/23 | |||||
| Univ. of Massachusetts, ICTC SARS-CoV-2 RT-PCR Assay | 4/26/23 | |||||
